Alteplase for Blood Flow Restoration in Hemodialysis Catheters - Full Text View

Sponsor:	University of Manitoba
Collaborator:	Hoffmann-La Roche
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00303420

Purpose

We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

Condition	Intervention	Phase
Thrombosis	Drug: Alteplase "push" protocol Drug: alteplase dwell arm	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Serious adverse events including major bleeding within 24 hours of alteplase administration [ Time Frame: 30 days post-last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	September 2004
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Alteplase used by normal dwell procedure	Drug: alteplase dwell arm alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary Other Names: Cathflo alteplase rTPA
Experimental: 2 Alteplase given by an new "push" protocol	Drug: Alteplase "push" protocol alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate. Other Names: CathFlo alteplase rTPA

Detailed Description:

Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults > 18 yrs old
Hemodialysis patients
Vascular access with a permanent catheter
No prior rt-PA use in the catheter over the previous 21 days
One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)

Exclusion Criteria:

Critically ill patients in the ICU setting.
Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (<48 hours), recent biopsy (<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
Hemodialysis catheter has been in the patient less than 14 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303420

Locations

Canada, Manitoba
Brandon General Hospital
Brandon, Manitoba, Canada, R7A 2B3
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Seven Oaks Hospital
Winnipeg, Manitoba, Canada, R2V 3M3
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 1Y3
Grand River Hospital
Kitchener, Ontario, Canada, N2G 1G3
Thunderbay Regional Health Sciences Centre
Thunderbay, Ontario, Canada, P7B 6V4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Maisonneuve Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4

Sponsors and Collaborators

University of Manitoba

Hoffmann-La Roche

Investigators

Principal Investigator:	Lavern M Vercaigne, Pharm.D.	University of Manitoba
Principal Investigator:	James M Zacharias, MD	University of Manitoba, Internal Medicine, Section of Nephrology

More Information

Publications:

Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33.

Responsible Party:	Lavern M. Vercaigne, University of Manitoba
ClinicalTrials.gov Identifier:	NCT00303420 History of Changes
Other Study ID Numbers:	B2003:119
Study First Received:	March 15, 2006
Last Updated:	December 17, 2008
Health Authority:	Canada: Health Canada

Keywords provided by University of Manitoba:

catheter
hemodialysis
dysfunction
thrombolytic
alteplase

Additional relevant MeSH terms:

Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on February 12, 2012